Pancreatic Cyst Fluid Specimen Collection

M
Mohammad Al-Haddad, MD

Primary Investigator

Enrolling By Invitation
18-100 years
All
Phase N/A
200 participants needed
2 Locations

Brief description of study

Sponsor will receive de-identified leftover human pancreatic cyst fluid, which was collected according to the clinical sites’ standard of care. Pancreatic cysts are very common with the majority incidentally identified. There are several types of pancreatic cysts; some types can contain cancer or have malignant potential, whereas others are benign. However, even the types of cysts with malignant potential rarely progress to cancer.  Procedures using local site collection processes. The planned use of these residual samples is to support the activities of product development lifecycle testing, verification and validation testing, on-market products support, and research studies for all diagnostic products.

Detailed description of study

The proposed multiplexed assays leverage Amplified Sciences’ proprietary reagents for isotope-dilution, surface-enhanced Raman spectroscopy (IDSERS) to detect multiple biomarkers on a single instrument. This innovative ultrasensitive detection platform enables the use of a minimal volume of cyst fluid to deliver a potential solution that both rules out unnecessary procedures (via highly accurate mucinous vs. non-mucinous detection) and identifies high risk malignant cysts to support surgical intervention decisions in a simple, cost-effective laboratory operations workflow. The quantification of low amounts of multiple biomarkers offers a significant alternative to currently available clinical assay systems.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: biomarkers, pancreatic cyst
  • Age: Between 18 Years - 100 Years
  • Gender: All

Inclusion Criteria:
  • a) Patients 18 years of age or older
    b) Cross sectional imaging studies demonstrating a pancreatic cyst at least 12 mm in size where fluid sampling can aid in patient’s management
    c) Has the subject willingly given written consent?
    d) Is the subject undergoing EUS-FNA to collect pancreatic cyst fluid as a part of standa) Patients diagnosed with cancer in the past 5 years excluding skin cancer.
    b) Pregnant or lactating females.
    c) Patients with contraindications to moderate or deep procedural sedation (necessary for the conduct of the endoscopic ultrasound) like major cardiorespiratory illness. 
    d) Patients with contraindications to fine needle aspiration of a pancreatic cyst like being on blood thinners 
    e) Incarcerated individuals or patients unable to provide informed consent to undergo the endoscopic ultrasound procedure. 
    f) EUS-FNA was NOT performed during the procedure
    g) FNA fluid collected was less than 50 uL during procedure
  • ard patient care?

Exclusion Criteria:

Updated on 01 Aug 2024. Study ID: 14378; GI-AMPLIFIED-AMP101
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